FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: UNIQUE DEVICE IDENTIFIER REQUIREMENTS FOR COMBINATION PRODUCTS; DRAFT GUIDANCE FOR INDUSTRY AND FDA STAFF; AVAILABILITY

WASHINGTON, June 26 -- Food and Drug Administration has issued a notice called: Unique Device Identifier Requirements for Combination Products; Draft Guidance for Industry and FDA Staff; Availability.

The notice was published in the Federal Register on June 26 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled "Unique Device Identifier (UDI) Requirements for Combination Products." This draft guidance is intended to assist industry and FDA staff in understanding how FDA's unique device identifier (UDI) requirements apply to combination products with device ...